Product Regulatory Engineer - Lead Biostatistician

Job Description Summary

The Product Regulatory Engineer - Lead Biostatistician is responsible for activities contributing to regulatory submissions for AI-driven medical software and devices within the General Imaging and Primary Care Business. This position bridges engineering, regulatory affairs, and biostatistics, ensuring that validation studies, data analysis, and regulatory documentation meet the highest standards required by global agencies (FDA, NMPA, etc.). The ideal candidate will leverage their biostatistics expertise to design, analyze, and justify validation datasets and metrics, while streamlining regulatory processes for the product engineering team.

Job Description

Roles and Responsibilities

Regulatory Study Design & Data Management

• Define validation dataset requirements (size, demographics, sites) in compliance with regulatory guidance.
• Acquire, clean, and document datasets for regulatory validation, ensuring data integrity and traceability.
• Design and oversee regulatory test plans and procedures, including dry runs and iterative improvements.
• Organize and index validation data and metadata for efficient analysis and reporting.

Statistical Analysis

• Perform advanced statistical analyses (e.g., power calculations, Wilcoxon Ranked Sign Test, Bland-Altman etc.) to justify dataset size and model performance.
• Generate and interpret statistics from reader studies and other validation experiments.
• Provide statistical reasoning behind Reader studies and documentation for regulatory submissions, addressing agency feedback.

Regulatory Documentation & Submission

• Write and review regulatory reports (e.g., FDA 510k, NMPA) with a focus on statistical rigor and clarity.
• Collaborate with engineering and regulatory affairs to ensure alignment with the latest regulatory requirements and best practices.
• Respond to regulatory agency feedback, providing statistical and technical justifications as needed.

Project Management & Cross-functional Collaboration

• Coordinate with clinical experts, data annotators, and arbitrators to ensure validation studies meet regulatory standards.
• Track regulatory landscape changes and update processes accordingly.
• Support the creation and standardization of regulatory processes and documentation for future teams.

Required Qualifications

· Advanced degree (MS/PhD) in Biostatistics, Statistics, Biomedical Engineering, or related field.

· Experience in regulatory submissions for medical devices or software (FDA, NMPA, or similar).

· Strong proficiency in statistical analysis, experimental design, and data management.

· Familiarity with AI/ML model validation and performance metrics.

· Excellent written and verbal communication skills, especially in technical and regulatory documentation.

· Ability to manage multiple projects and context-switch efficiently in a fast-paced environment.

· Experience working with cross-functional teams (engineering, clinical, regulatory).

Desired Characteristics

· Experience with regulatory test planning and reader studies.

· Knowledge of medical imaging data formats and annotation tools (e.g., V7).

· Project management experience in a regulated environment.

· Familiarity with regulatory feedback cycles and deficiency response processes.

Additional Information

While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.